February 17, 2012


The rest of February should be quiet (i.e., work going on at the company, but no significant clinical- or regulatory-related news event or PR) aside from, potentially, one non-clinical- or non-transaction-related item. Although this is a change in my expectations (i.e., a quiet remainder of the month primarily for clinical-related events), the change does not concerns me.

This blog can boast nearly 200 unique regular visitors from about 150 cities in the U.S. and Europe. When I first started writing posts, there was much in my proverbial notepad from which to share and upon which to expound and expand. My goals were and still are to share due diligence, conduct analysis and provide opinions on the company. Going forward, I will not blog as frequently (I'm not a journalist or writer, so if there's nothing to say or write, I won't). When I do, the posts are likely to come in bunches and should be driven primarily by news or PR.

There was speculation among a few shareholders that Provectus would announce their submission of the final protocol to the FDA for the pivotal MM Phase 3 trial, thereby establishing expectations about when the company could receive the SPA and, consequently, placing a timer on the situation. This hazarding a guess likely grew from management's contemplation of holding an investor conference call shortly after the January 18 PR to explain FDA guidance on trial design and agency meetings (and potentially changing their behavior and protocols to disseminating information).

I was asked about my view on holding such a conference call. I told management this could be good idea if they were prepared to answer all proffered questions on the SPA topic as well as on other topics. It would be a bad idea if they weren't prepared to answer all questions. Attendees were likely to press management on details that they likely were not going to be comfortable or able to divulge, and venture into other clinical areas where, again, management might not desire to answer some questions. I thought management should be prepared to answer all questions, or answer none (i.e., don't hold a conference call). In the end, management decided not to hold a call.

It will be highly unlikely that we will hear or learn about the submission of the final protocol. Doing so would be completely out of character for the company. It would be analogous to Provectus issuing a PR to tell the market of an upcoming EOP2 meeting with the FDA. They did not do this, except in the one case of Craig mentioning such at an investor-oriented conference last March (as a result, in the abundance of caution and simply conducting good process, the company filed an 8-K). Rather, the market will hear via PR about the official receipt of the SPA when the FDA informs the company it indeed has achieved it. My expectation of a mid- to late-March date for this event comes from the calculation of 45 days after January 18  and the assumption that no further iterations will be required (if there is an iteration or two or more, my expectation will change).

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